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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: 7HP349 Single Ascending Dose; Drug: 7HP349 Multiple Ascending Dose; Drug: 7HP349 Food Effect; Drug: Placebo Single Ascending Dose; Drug: Placebo Multiple Ascending Dose

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Secaucus, New Jersey, United States, 07094
      • Frontage Clinical Services Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7HP349 Capsules; Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over)	Drug: 7HP349 Single Ascending Dose; Part A: 7HP349 Capsules, Single Ascending Dose (SAD); Other Names: 7HP349 SAD; Drug: 7HP349 Multiple Ascending Dose; Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD); Other Names: 7HP349 MAD; Drug: 7HP349 Food Effect; Part C: 7HP349 Capsules, Food Effect; Other Names: 7HP349 FE
Placebo Comparator: Placebo Capsules; Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts)	Drug: Placebo Single Ascending Dose; Part A: Placebo Capsules, Single Ascending Dose (SAD); Other Names: Placebo SAD; Drug: Placebo Multiple Ascending Dose; Part B: Placebo Capsules, Multiple Ascending Dose (MAD); Other Names: Placebo MAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria	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	17 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 7 Hills Pharma, LLC
• Collaborators: Frontage Clinical Services, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 7HP-101a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No