NCT04508179

A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects

A Phase 1, Placebo-controlled, Within-Cohort Randomized, Double-blind, Single and Multiple Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of 7HP349 in Normal Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: 7 Hills Pharma, LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects

Detailed description

This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts. Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349. Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C: This is a randomized, open label, two-treatment, three-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	7HP349 Single Ascending Dose	Part A: 7HP349 Capsules, Single Ascending Dose (SAD)
DRUG	7HP349 Multiple Ascending Dose	Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD)
DRUG	Placebo Single Ascending Dose	Part A: Placebo Capsules, Single Ascending Dose (SAD)
DRUG	Placebo Multiple Ascending Dose	Part B: Placebo Capsules, Multiple Ascending Dose (MAD)
DRUG	7HP349 Food Effect	Part C: 7HP349 Capsules, Food Effect

Timeline

• Start date: 2020-10-28
• Primary completion: 2021-10-25
• Completion: 2021-10-25
• First posted: 2020-08-11
• Last updated: 2021-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study