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

NCT04508179 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 7HP-101a
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pharmacokinetics of 7HP349 in healthy male subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose (OPD)

  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)

  17 days

• Pharmacokinetics of 7HP349 in healthy male subjects as assessed by exposure in urine towards determination of the optimal pharmacokinetic dose (OPD)

  17 days

• Pharmacokinetics of 7HP349 in healthy male subjects as assessed by renal clearance (CLr) towards determination of the optimal pharmacokinetic dose (OPD)

  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

  28 days

Study Arms (2)

7HP349 Capsules

EXPERIMENTAL

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; Drug: 7HP349 Multiple Ascending Dose; Drug: 7HP349 Food Effect

Placebo Capsules

PLACEBO COMPARATOR

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

Drug: Placebo Single Ascending Dose; Drug: Placebo Multiple Ascending Dose

Interventions

7HP349 Single Ascending Dose DRUG

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

Also known as: 7HP349 SAD

7HP349 Capsules

7HP349 Multiple Ascending Dose DRUG

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

Also known as: 7HP349 MAD

7HP349 Capsules

Placebo Single Ascending Dose DRUG

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

Also known as: Placebo SAD

Placebo Capsules

Placebo Multiple Ascending Dose DRUG

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

Also known as: Placebo MAD

Placebo Capsules

7HP349 Food Effect DRUG

Part C: 7HP349 Capsules, Food Effect

Also known as: 7HP349 FE

7HP349 Capsules

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 7 Hills Pharma, LLC: lead
• Frontage Clinical Services, Inc.: collaborator

Study Sites (1)

Frontage Clinical Services Inc.

Secaucus, New Jersey, 07094, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 11, 2020
• Study Start: October 28, 2020
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (1)