Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, and Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of D-0120 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097405
• Other study ID #: IBIO-203
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2019
• Est. completion date: November 18, 2020

Study information

• Verified date: February 2021
• Source: InventisBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 18, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subjects must be medically documented as healthy at physical examination

• Moderate smokers or non-smokers

• Subjects must be between the ages of 18 and 60

• Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)

• Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females

• Females must be non-pregnant and non-lactating, and either surgically sterile at least 6 months prior to the first study drug administration or post-menopausal for 12 months or greater

• Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner must be willing to use an acceptable contraceptive method throughout the study and for 90 days after the last study drug administration

• Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study administration

• Subjects must have a complete blood count and platelet count within the normal range

• Subjects must have a normal urinalysis

• Subjects must have a normal estimated glomerular filtration rate

• Subjects must have a normal ECG

• Subjects must be able to understand the study procedures, risks involved and be able to comply with the study and follow-up procedures

• Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion Criteria:

• Subjects with any history or clinical manifestations of disorders

• Subjects who have any history or suspicion of kidney stones

• Subjects who are HIV, Hep B or Hep C positive

• History of significant allergic reactions to any drug

• Clinically significant ECG abnormalities

• History of significant drug abuse within 1 year prior to screening or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior to screening

• Subjects who have used prescription dugs, over the counter drugs or herbal remedies within 14 days before day 1

• Positive urine drug screen, alcohol breath at screening

• Subjects had undergone major surgery within 3 months

• Women who are pregnant or breastfeeding

• History of significant alcohol abuse

• Subjects who consumed Seville oranges-or grapefruit-containing food or beverages within 7 days before Day 1 and during the entire study duration.

• Subjects with any condition that, in the judgement of the investigator, would place him/her at undue risk

• Participation in a clinical research study involving the administration of an investigation or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to first dose

• Donation of plasma within 7 days prior to dosing

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• D-0120
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
• Placebo oral tablet
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo

Locations

Country	Name	City	State
United States	Syneos Health	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
InventisBio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects with treatment related adverse events as assessed	Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs	Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6)
Secondary	Time to observed Cmax (Tmax)for D-0120	Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax	Timeframe: Day 1-Day7
Secondary	Area under the plasma concentration-time curve (AUC) for D-0120	Blood samples will be collected to assess plasma concentration of D-0120 at a series of timepoints to derive AUC	Day 1-Day 7
Secondary	Maximum Observed Plasma Concentration (Cmax) of D-0120	Blood samples will be collect to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax	Day 1-Day 7