Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers

NCT02238834 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: FP02C-14-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo controlled, single and multiple ascending dose study to assess the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects. Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).

Conditions

Healthy

Keywords

Phase I; Safety and tolerability; Pharmacokinetic; Randomized; Double Blind; Placebo-Controlled; Single- & Multiple Dose Escalation; FP-025; MMP-12 inhibitor

Outcome Measures

Primary Outcomes (2)

• Single ascending dose (SAD): Safety and tolerability of FP-025

  Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring

  9 days

• Multiple ascending dose (MAD): Safety and tolerability of FP-025

  Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring

  13 days

Secondary Outcomes (2)

• Single ascending dose (SAD): Pharmacokinetics of FP-025

  2 days

• Multiple ascending dose (MAD): Pharmacokinetics of FP-025

  6 days

Study Arms (4)

SAD Cohorts 1-8 Experimental Arm

EXPERIMENTAL

Drug: FP-025

SAD Cohorts 1-8 Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

MAD Cohorts 1 through 4 Experimental Arm

EXPERIMENTAL

Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).

Drug: FP-025

MAD Cohorts 1 through 4 Placebo Arm

PLACEBO COMPARATOR

Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).

Drug: Placebo

Interventions

FP-025 DRUG

Subjects will receive single doses of 200 to up to 800 mg of FP-025 (API-in-capsule) in a dose escalation format (cohorts 1-3). Subjects will receive single doses of 50 to up to 450 mg of FP-025 (ASD-in-capsule) in a dose escalation format (cohorts 4-8).

SAD Cohorts 1-8 Experimental Arm

Placebo DRUG

Subjects will receive single doses of FP-025 matching placebo (capsule) in a dose escalation format.

SAD Cohorts 1-8 Placebo Arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged ≥20 and ≤65 years with a BMI ≥18 kg/m2 and ≤30 kg/m2.
• A resting pulse ≥50 bpm and ≤100 bpm at the Screening Visit.
• A resting systolic blood pressure of ≤140 mmHg and a resting diastolic blood pressure of ≤90 mmHg at the Screening Visit and the Safety Baseline Visit.
• Baseline laboratory test values within reference ranges based on the blood and urine samples taken at the Screening Visit. Out of normal ranges values (except for liver parameters) may be accepted by the investigator, if not clinically significant.
• The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
• Adequate contraception (double-barrier) will be applied during and until 3 months after completion of the study.
• Signed Informed Consent prior to any study related procedures.
• Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

You may not qualify if:

• The subject has a substance abuse-related disorder or has a significant history of drug or alcohol abuse, or a history of drug abuse or a history of substance abuse deemed significant by the investigator.
• The subject should avoid alcohol for at least 5 days before admission into the clinic.
• The subject has taken any investigational products within 30 days prior to the first dose of study product.
• The subject has a history of severe drug allergy or hypersensitivity or food allergy.
• The subject has a history or presence of any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (in particular diabetes or pre-diabetes), haematological, dermatological, venereal, neurological, chronic infectious or psychiatric disease or other major disorder.
• The subject has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years prior to the first dose of study product.
• The subject has a history of abdominal surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or non-peripheral vascular surgery within 6 months prior to the first dose of study product.
• The subject has any concurrent illness that may affect the particular target or absorption, distribution, and elimination of the study product.
• The subject has had a clinically significant illness within 4 weeks prior to the first dose of study product.
• The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study product.
• The subject has donated blood more than 250 mL within 2 months prior to the first dose of study product.
• The subject has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV).
• The subject is a current smoker or uses other nicotine containing products. Ex-smokers must have ceased smoking at least 6 months prior to the first dose of study product (+ \<10 pack years).
• The subject has tested positive at the Screening Visit and at the Safety Baseline Visit for drugs of abuse (amphetamine, cannabinoid, cocaine, morphine, and phencyclidine).
• The subject's corrected QT interval (QTc) (Bazett's or Fridericia's correction) is \>450 ms as read on the printout of the ECG produced by the ECG equipment and evaluated by the investigator at the Screening Visit and at the Safety Baseline Visit. An out-of-range or abnormal ECG may be repeated. In total, 3 ECGs should be recorded consecutively and the investigator must evaluate the triplicate ECG. If the subject's QTc is \>450 ms on at least 2 ECGs, the subject must be excluded.

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead
• QPS-Qualitix: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

• Abd-Elaziz K, Voors-Pette C, Wang KL, Pan S, Lee Y, Mao J, Li Y, Chien B, Lau D, Diamant Z. First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects. Clin Drug Investig. 2021 Jan;41(1):65-76. doi: 10.1007/s40261-020-00981-9. Epub 2020 Dec 17.

  PMID: 33331980 DERIVED

MeSH Terms

Interventions

FP-025

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 12, 2014
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

TW (1)