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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: 7HP349 Single Ascending Dose; Drug: Placebo Single Ascending Dose; Drug: Placebo Multiple Ascending Dose; Drug: 7HP349 Multiple Ascending Dose; Drug: 7HP349 Food Effect

• Registration Number: NCT04508179
• Lead Sponsor: 7 Hills Pharma, LLC

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-10-28
• Status Verified: 2021-10
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Healthy males between the ages of 18 and 45 years, inclusive
• Normal clinical chemistry, hepatic function, hematology, thyroid function
• Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg
• Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation
• Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) ≥ 1.1, and positive Rubella: AI ≥ 1.0

Exclusion Criteria

• Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator
• History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
• Current treatment or treatment within 30 days with another investigational medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
7HP349 Capsules	7HP349 Single Ascending Dose	Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over)
7HP349 Capsules	7HP349 Food Effect	Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over)
Placebo Capsules	Placebo Multiple Ascending Dose	Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts)
7HP349 Capsules	7HP349 Multiple Ascending Dose	Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over)
Placebo Capsules	Placebo Single Ascending Dose	Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria	17 days	Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by plasma exposure (AUClast and/or AUCinf) towards determination of the optimal pharmacokinetic dose (OPD)	17 days	Determination of plasma exposure (AUClast and/or AUCinf)
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose (OPD)	17 days	Determination of maximum plasma concentration (Cmax)
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by exposure in urine towards determination of the optimal pharmacokinetic dose (OPD)	17 days	Determination of exposure in urine
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by renal clearance (CLr) towards determination of the optimal pharmacokinetic dose (OPD)	17 days	Determination of renal clearance (CLr)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fed individuals	28 days	Fed prandial state, determination of maximum plasma concentration (Cmax)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fed individuals	28 days	Fed prandial state, determination of plasma exposure (AUClast and/or AUCinf)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fasted individuals	28 days	Fasted prandial state, determination of maximum plasma concentration (Cmax)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fasted individuals	28 days	Fasted prandial state, determination of plasma exposure (AUClast and/or AUCinf)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the maximum plasma concentration (Cmax) in fed vs. fasted individuals	28 days	Determination of Geometric Mean Ratio (GMR) of fed:fasted Cmax
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the plasma exposure (AUClast and/or AUCinf) in fed vs. fasted individuals	28 days	Determination of Geometric Mean Ratio (GMR) of fed:fasted AUClast and/or AUCinf

Trial Locations

Locations (1)

Frontage Clinical Services Inc.; 🇺🇸 Secaucus, New Jersey, United States