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

7 Hills Pharma, LLC60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Solid Tumor

Interventions

7HP349 Single Ascending DoseDRUG

Part A: 7HP349 Capsules, Single Ascending Dose (SAD)

7HP349 Multiple Ascending DoseDRUG

Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD)

Placebo Single Ascending DoseDRUG

Part A: Placebo Capsules, Single Ascending Dose (SAD)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Frontage Clinical Services Inc.

Secaucus, New Jersey, United States

Outcomes

Primary Outcomes

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

Time frame: 17 days

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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