A Phase 1 Study of EXT608 in Healthy Adults

Safety Issues Clinical Trial

Official title:

EXT608 in Human Healthy Adults; A First-in-Human, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408663
• Other study ID #: EXT608-101
• Secondary ID: DK107231
• Status: Completed
• Phase: Phase 1
• Start date: July 21, 2022
• Est. completion date: June 13, 2023

Study information

• Verified date: September 2023
• Source: Extend Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.

Description:

This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, PK, and PD of EXT608 in healthy adult participants.

Participants will be enrolled into 1 of up to 6 planned single dose cohorts in ascending fashion.

Each cohort will consist of 4 participants randomized to receive either EXT608 or placebo, whereby 3 will receive a single injection of EXT608 and 1 will receive matching placebo.

Up to 6 dosing cohorts are planned with no single dose escalation to exceed a 3-fold dose increment. A Data Monitoring Board will review the seven-day safety data in each cohort before authorizing the initiation of the next cohort.

A screening visit will take place within 28 days of dosing. Eligible participants for each cohort will be admitted to the Clinical Research Unit (CRU) 1 day prior to dosing and remain in the CRU through at least 72 hours after dosing for safety and PK assessments before discharge. The total confinement period will be 4 nights, unless extended for management of AEs at the discretion of the Investigator

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Male or female between 18 and 55 years of age.

2. Body mass index between 18.5 and 32 kilogram per square meter (kg/m2), inclusive, with a body weight greater than or equal to (>=) 45 kg.

3. In general good medical health with no clinically significant or relevant abnormalities,

4. A clinical safety laboratory parameter of hemoglobin greater than (>) 11.7 gram per deciliter (g/dl) (females) or 13.1 g/dl (males) and less than (<) 16 g/dl (females) or 17.4 g/dl (males) or, if out of this range, deemed not clinically significant by the Investigator.

5. Total Se-Ca within laboratory normal limits.

6. Serum parathyroid hormone (PTH) concentration within normal laboratory limits.

Exclusion Criteria:

1. Evidence of clinically significant (CS) neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, or psychiatric disorder

2. History of drug abuse

3. Currently using any medication (including over-the-counter [OTC], herbal or homeopathic preparations

4. Pregnant, nursing, or planning a pregnancy during the course of or within 3 months of completing this study

5. History of cancer or other malignancy, with the exception of basal cell carcinoma that has been in remission for at least 5 years

6. Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or a human immunodeficiency virus (HIV)

7. ALT and/or AST >1.5 the ULN

8. Increased baseline risk for osteosarcoma

Related Conditions & MeSH terms

• Safety Issues

Intervention

Drug:
• EXT608
EXT608 is an investigational drug administered via subcutaneous injection

Other:
• Placebo
matching placebo administered via subcutaneous injection

Locations

Country	Name	City	State
United States	PRA	Lenexa	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
Extend Biosciences Inc.	Integrated Medical Development, National Institutes of Health (NIH), Pharmaceutical Research Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of EXT608 - Adverse events	Monitoring of treatment-emergent Adverse Events	Day 0 to Day 28
Primary	Safety and tolerability of EXT608-clinical laboratory assessments	Frequency and severity of post-dose change from baseline in hematology, serum chemistry and urinalysis	Day 0 to Day 28
Primary	Safety and tolerability of EXT608- ECG PR interval	Frequency and severity of post-dose change from baseline of 12-lead ECG PR interval	Day 0 to Day 28
Primary	Safety and tolerability of EXT608- ECG QRS interval	Frequency and severity of post-dose change from baseline of 12-lead ECG QRS interval	Day 0 to Day 28
Primary	Safety and tolerability of EXT608- ECG RR interval	Frequency and severity of post-dose change from baseline of 12-lead ECG RR interval	Day 0 to Day 28
Primary	Safety and tolerability of EXT608- ECG QT interval	Frequency and severity of post-dose change from baseline of 12-lead ECG QT interval	Day 0 to Day 28
Primary	Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Blood pressure	Frequency and severity of post-dose change from baseline Blood pressure measurement	Day 0 to Day 28
Primary	Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Pulse rate	Frequency and severity of post-dose change from baseline Pulse rate measurement	Day 0 to Day 28
Primary	Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Respiratory rate	Frequency and severity of post-dose change from baseline Respiratory rate measurement	Day 0 to Day 28
Primary	Safety and tolerability of EXT608 - Physical exam	Physical exam based upon symptoms reported by participant	Day 0 to Day 28
Primary	Safety and tolerability of EXT608- injection site reactions	Percentage of participants with injection site reactions	Day 0 to Day 28
Secondary	Single dose PK- AUC	Area under the curve	Up to Day 3
Secondary	Single dose PK-Cmax	Maximum observed concentration	Up to Day 3
Secondary	Single dose PK - Tmax	time to reach maximum observed plasma concentration	up to Day 3