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

NCT ID: NCT04508179

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2021-10-25

Brief Summary

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

Detailed Description

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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

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Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This study consists of three parts, Part A, Part B and Part C, which will be undertaken sequentially. Part A is a SAD study to determine the safety, tolerability and PK of 7HP349 in healthy male subjects, and to define the OPD. Part B is a MAD study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C is a crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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7HP349 Capsules

Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over)

Group Type EXPERIMENTAL

7HP349 Single Ascending Dose

Intervention Type DRUG

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

7HP349 Multiple Ascending Dose

Intervention Type DRUG

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

7HP349 Food Effect

Intervention Type DRUG

Part C: 7HP349 Capsules, Food Effect

Placebo Capsules

Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts)

Group Type PLACEBO_COMPARATOR

Placebo Single Ascending Dose

Intervention Type DRUG

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

Placebo Multiple Ascending Dose

Intervention Type DRUG

Part B: Placebo Capsules, Multiple Ascending Dose (MAD)

Interventions

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7HP349 Single Ascending Dose

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

Intervention Type DRUG

7HP349 Multiple Ascending Dose

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

Intervention Type DRUG

Placebo Single Ascending Dose

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

Intervention Type DRUG

Placebo Multiple Ascending Dose

Part B: Placebo Capsules, Multiple Ascending Dose (MAD)

Intervention Type DRUG

7HP349 Food Effect

Part C: 7HP349 Capsules, Food Effect

Intervention Type DRUG

Other Intervention Names

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7HP349 SAD 7HP349 MAD Placebo SAD Placebo MAD 7HP349 FE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Frontage Clinical Services, Inc.

UNKNOWN

Sponsor Role collaborator

7 Hills Pharma, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Frontage Clinical Services Inc.

Secaucus, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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7HP-101a

Identifier Type: -

Identifier Source: org_study_id