Study of IPG1094 in Healthy Participants

Safety Issues Clinical Trial

Official title:

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Orally Administered IPG1094 in Healthy Adult Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112159
• Other study ID #: IPG1094-A001
• Status: Recruiting
• Phase: Phase 1
• Start date: September 27, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: October 2021
• Source: Nanjing Immunophage Biotech Co., Ltd
• Contact: Zhang Qi, doctor
• Phone: 13074800770
• Email: qzhang[@]immunophage.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of single dose orally administered IPG1094 in healthy adult participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: July 30, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Participants must meet all of the following criteria to be included in the study:

Demography

1. Healthy adult male or female participants between 18 and 50 years of age (inclusive).

2. Body weight between 50 and 100 kg (inclusive) and body mass index (BMI) within 18~32 kg/m2 (inclusive).

Health status

3. In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination (including measurement of blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests.

Vital signs (measured after resting for 5 minutes seated position) within normal range, or outside the normal range and not considered clinically significant by the Investigator.

Standard 12-lead ECG parameters (recorded after resting for 5 minutes in supine position) in the following ranges; corrected QT interval(QTc) (Fridericia algorithm recommended) = 450 ms for males and 470 ms for females, and normal ECG tracing, or abnormal ECG tracing not considered clinically relevant by the Investigator.

Laboratory parameters demonstrating no clinically significant abnormalities, as determined by the Investigator. A total bilirubin outside the normal range may be acceptable if total bilirubin does not exceed 1.5 × upper limit of normal(ULN) conjugated bilirubin (with the exception of a participant with documented Gilbert syndrome).

4. A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).

5. Female participants must not be pregnant or breastfeeding and must use an effective contraception method (as described in Section 4.5.4), with the exception of participants who have undergone sterilization in the preceding 3 months, or who are postmenopausal.

A woman of childbearing potential (WOCBP) must undergo pregnancy testing prior to the first dose of the Investigational Medicinal Product (IMP). The participant must be excluded from the study if the serum pregnancy test is positive.

A postmenopausal state is defined as 12 months of amenorrhea without an alternative medical cause. In the absence of 12 months of amenorrhea, menopause may be confirmed by follicle stimulating hormone(FSH) measurement (> 40 IU/L or milli-International unit(mIU)/mL).Females on Hormonal Replacement therapy (HRT ), where menopausal status is indeterminate, will be required to use a non-estrogen hormonal contraceptive method if participants wish to continue their HRT during the study. Participants must otherwise discontinue HRT to allow for confirmation of postmenopausal status prior to enrollment in the study.

Regulation

6. Provide written informed consent prior to undertaking any study-related procedures.

7. Must not be under any administrative or legal supervision or under institutionalization as per a regulatory or juridical order.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from the study:

Medical history and clinical status

1. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.

2. Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined as vomiting more than twice a month).

3. Made a blood donation of any volume within 2 months prior to the first dose.

4. Symptomatic postural hypotension, irrespective of actual decrease in blood pressure, or asymptomatic postural hypotension with a decrease in systolic blood pressure =30 mmHg within 3 minutes of moving from supine to standing position.

5. Presence or history of drug hypersensitivity, or anaphylactic reaction, diagnosed and treated by a physician.

6. Known hypersensitivity to any component of the IMP formulation.

7. History or presence of drug or alcohol abuse (defined as alcohol consumption more than 2 units per day on a regular basis).

8. Regular smoking (defined as more than 5 cigarettes or equivalent per week), or unable to stop smoking during the study. Occasional smokers may be enrolled.

9. Excessive consumption of beverages containing xanthine bases (defined as more than 4 glasses per day).

Interfering substances

10. Any medication, including St John's Wort, within 14 days prior to administration of the first dose or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception, menopausal hormone replacement therapy, or occasional paracetamol at doses up to 2g/day.

11. Any consumption of grapefruit or products containing grapefruit within 5 days prior to the first dose administration.

12. Any vaccination in the 28 days prior to administration of the first dose.

General conditions

13. Any participant who, in the judgment of the Investigator, is likely to be non-compliant during the study, or to be unable to cooperate due to language problems or poor mental development.

14. Any participant who enrolled in or participated in any other clinical study involving an investigational medicinal product, or in any other type of medical research within 1 month or within 5 times the elimination half-life prior to administration of the first dose.

15. Any participant who cannot be contacted in the case of an emergency.

16. Any participant who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof directly involved in conducting the study or any person dependent on (employees or immediate family members) the study site, the Investigator or the Sponsor.

Biological status

17. Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBcAb), anti-hepatitis C virus antibodies (anti-HCV), anti-human immunodeficiency virus 1 and 2 antibodies(anti-HIV1 and anti-HIV2 Ab).

18. Positive alcohol test.

19. Any participant in whom venous blood collection is difficult.

Related Conditions & MeSH terms

• Safety Issues

Intervention

Drug:
• IPG1094
The IPG1094 drug product is supplied as oral tablet dosage form, containing two strengths: 50 mg and 100 mg, respectively, which contain IPG1094.
• placebo
Matching placebo tablets to IPG1094 50mg and 100mg

Locations

Country	Name	City	State
Australia	Scientia Clinical Research Ltd	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Immunophage Biotech Co., Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of all adverse events	Evaluation of adverse events	Up to 8 days
Primary	RBC	Evaluation of Hematology	Up to 8 days
Primary	white blood cell count (WBC)	Evaluation of Hematology	Up to 8 days
Primary	platelet count (PLT)	Evaluation of Hematology	Up to 8 days
Primary	haemoglobin (HGB)	Evaluation of Hematology	Up to 8 days
Primary	mean corpuscular hemoglobin	Evaluation of Hematology	Up to 8 days
Primary	mean corpuscular hemoglobin concentration	Evaluation of Hematology	Up to 8 days
Primary	Hematocrit	Evaluation of Hematology	Up to 8 days
Primary	mean corpuscular volume (MCV)	Evaluation of Hematology	Up to 8 days
Primary	absolute differential leukocyte count (eosinophils)	Evaluation of Hematology	Up to 8 days
Primary	absolute differential leukocyte count (monocytes)	Evaluation of Hematology	Up to 8 days
Primary	absolute differential leukocyte count (lymphocytes)	Evaluation of Hematology	Up to 8 days
Primary	absolute differential leukocyte count (basophils)	Evaluation of Hematology	Up to 8 days
Primary	absolute differential leukocyte count (neutrophils)	Evaluation of Hematology	Up to 8 days
Primary	Temperature (°C )	Evaluation of Vital Signs	Up to 8 days
Primary	Respiration rate	Evaluation of Vital Signs	Up to 8 days
Primary	Pulse rate	Evaluation of Vital Signs	Up to 8 days
Primary	Blood pressure (both systolic and diastolic)	Evaluation of Vital Signs	Up to 8 days
Primary	Standard 12-lead ECG - heart rate	Evaluation of Electrocardiograms	Up to 8 days
Primary	Standard 12-lead ECG - QTcF	Evaluation of Electrocardiograms	Up to 8 days
Primary	Standard 12-lead ECG - PR	Evaluation of Electrocardiograms	Up to 8 days
Primary	Standard 12-lead ECG - QRS	Evaluation of Electrocardiograms	Up to 8 days
Primary	Standard 12-lead ECG - QT	Evaluation of Electrocardiograms	Up to 8 days
Primary	Alanine aminotransferase (ALT)	Evaluation of Serum Chemistry	Up to 8 days
Primary	albumin (ALB)	Evaluation of Serum Chemistry	Up to 8 days
Primary	alkaline phosphatase (ALP)	Evaluation of Serum Chemistry	Up to 8 days
Primary	aspartate aminotransferase (AST)	Evaluation of Serum Chemistry	Up to 8 days
Primary	total bilirubin (TBil)	Evaluation of Serum Chemistry	Up to 8 days
Primary	Urea	Evaluation of Serum Chemistry	Up to 8 days
Primary	calcium (Ca)	Evaluation of Serum Chemistry	Up to 8 days
Primary	chloride (Cl)	Evaluation of Serum Chemistry	Up to 8 days
Primary	cholesterol (CHO)	Evaluation of Serum Chemistry	Up to 8 days
Primary	creatinine (Cr)	Evaluation of Serum Chemistry	Up to 8 days
Primary	creatine kinase (CK)	Evaluation of Serum Chemistry	Up to 8 days
Primary	glucose (Glu)	Evaluation of Serum Chemistry	Up to 8 days
Primary	lactate dehydrogenase (LDH)	Evaluation of Serum Chemistry	Up to 8 days
Primary	phosphate (P)	Evaluation of Serum Chemistry	Up to 8 days
Primary	potassium (K)	Evaluation of Serum Chemistry	Up to 8 days
Primary	sodium (Na)	Evaluation of Serum Chemistry	Up to 8 days
Primary	total protein (TP)	Evaluation of Serum Chemistry	Up to 8 days
Primary	Prothrombin time (PT)	Evaluation of Serum Coagulation	Up to 8 days
Primary	activated partial thromboplastin time (APTT)	Evaluation of Serum Coagulation	Up to 8 days
Primary	fibrinogen	Evaluation of Serum Coagulation	Up to 8 days
Primary	international normalized ratio (INR)	Evaluation of Serum Coagulation	Up to 8 days
Primary	pH	Evaluation of Urinalysis	Up to 8 days
Primary	Bilirubin (U-BIL)	Evaluation of Urinalysis	Up to 8 days
Primary	glucose (GLU)	Evaluation of Urinalysis	Up to 8 days
Primary	urine erythrocytes (U-RBC)	Evaluation of Urinalysis	Up to 8 days
Primary	ketones (U-KET)	Evaluation of Urinalysis	Up to 8 days
Primary	Urinary leukocyte (U-LEU)	Evaluation of Urinalysis	Up to 8 days
Primary	nitrites (U-NIT)	Evaluation of Urinalysis	Up to 8 days
Primary	protein (U-PRO)	Evaluation of Urinalysis	Up to 8 days
Primary	specific gravity (U-SG)	Evaluation of Urinalysis	Up to 8 days
Primary	urobilinogen (URO)	Evaluation of Urinalysis	Up to 8 days
Secondary	Maximum plasma concentration(Cmax)	Pharmacokinetic (PK) parameters after a single oral dose of IPG1094	Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.
Secondary	Time to Cmax (tmax)	Pharmacokinetic (PK) parameters after a single oral dose of IPG1094	Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.
Secondary	Area under the serum concentration-time curve (AUC[0-t]	Pharmacokinetic (PK) parameters after a single oral dose of IPG1094	Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.
Secondary	Area under the serum concentration-infinity curve AUC[0-infinity]	Pharmacokinetic (PK) parameters after a single oral dose of IPG1094	Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.
Secondary	Apparent terminal phase half-life (t1/2)	Pharmacokinetic (PK) parameters after a single oral dose of IPG1094	Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.