To Evaluate Safety, Tolerability andPharmacokinetics of AB1001 Topical Gel in Healthy Adult Male Volunteers

Phase 1

Not yet recruiting

• Conditions: Healthy, willing, adult male volunteers of age between 18 and 45years (both inclusive), with Body Mass Index (18.50 to 30.00 kg/m2(both inclusive) and minimum of 45 kg weight.

• Registration Number: CTRI/2022/02/039885
• Lead Sponsor: AHAMMUNE BIOSCIENCES PRIVATE LIMITED

Brief Summary

The overall objective of the study is to assess the safety, tolerability and pharmacokinetics of topical AB1001 gel in healthy volunteers.

Primary Objective: To evaluate safety and tolerability of AB1001 topical gel when establishing the MTD (Maximum Tolerated Dose) or the MAD (Maximum Administered Dose) in healthy subjects [Time Frame: 2 weeks] as assessed by:

1. General Examination of the skin for any local inflammatory reactions and local intolerance

2. Safety concerns as measured by:

3. Clinical Signs and Symptoms by means of Physical Examination, Vital signs, and ECG.

4. Clinical Chemistry: CBC, LFT, RFT, Blood Glucose and Thyroid Profile.



Secondary Objective:

1. Single dose PK: Quantification of AB1001 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- first dosing with AB1001 gel on Day 1. Time points for sample collection: 30 minutes pre-morning dose and 1, 3, 6, 9, 12, 24 hours post-morning dose. Sample will be drawn to calculate Cmax, Tmax, AUC(0-12), AUC(0-24).

2. Multi dose PK: Quantification of AB1001 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- morning dosing with AB1001 gel on Day 14. Time points for sample collection: 30 minutes premorning dose and 1, 3, 6, 9, 12, 24 hours post-morning dose. Sample will be drawn to calculate Cmax, Tmax, AUC(0-12), AUC(0-24).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-02
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Male subjects, aged ≥18 years and ≤ 45 years, with a confirmed healthy status as per standard screening procedure for healthy volunteers at the screening center.
• Subject is in good general health and free of any known uncontrolled disease state or physical condition which, in the opinion of the investigator, would interfere with the study assessments or put the subject at undue risk by study participation.
• Subjects must be willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator.
• Subjects must provide audio-visual and written informed consent prior to any study-specific procedure.
• Should have reliable access to the clinical trial center and available in the area for at least one month.

Exclusion Criteria

• Hemoglobin, white blood cell (WBC), platelets, alanine transaminase (ALT), and creatinine (Cr) outside of local lab normal range (subjects may be included at the investigator’s discretion for not clinically significant values outside of normal range).
• Subjects with a clinically significant abnormal thyroid-stimulating hormone (TSH) or free T4 at screening.
• Abnormal urinalysis as defined by positive urine glucose, protein, and hemoglobin.
• Subject can be included if investigator determine the abnormality is not clinically significant.
• Use of any Investigational vaccine within the last five years except for Covid-19 vaccines.
• Chronic systemic immunosuppressive medications 6.
• Recurrent receipt of blood products or immunoglobulins.
• Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status and participation in the study in the opinion of the Investigator.
• Any contraindication to repeated phlebotomy.
• History of or known active cardiac disease.
• Having active Tuberculosis.
• Psychiatric condition that precludes compliance with the protocol.
• Suspected or known current alcohol or drug abuse as per discretion of the PI.
• Any other finding that, in the judgment of the Investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a subject s ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study.
• Any skin disease or history of skin disease that may interfere with the study evaluation that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
• Subject who has a history of serious local infection (e.g., cellulitis, abscess) or systemic infection, or history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to the screening visit.
• History of allergic disorders including skin allergies and atopic diseases such as eczema, asthma and rhinoconjunctivitis.
• Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to enrollment into the study.
• Sexually active man with a partner of child-bearing potential not using barrier contraception during the trial and for a period of the study.
• Participation in a clinical trial for an investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) of screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of AB1001 topical gel	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15
when establishing the MTD (Maximum Tolerated Dose) or the MAD	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15
(Maximum Administered Dose) in healthy subjects -Time Frame: 2 weeks as	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15
assessed by:	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15
1. General Examination of the skin for any local inflammatory reaction and local intolerance	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15
Safety concerns as measured by:	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15
a. Clinical Signs and Symptoms as measured by Physical Examination, Vital	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15
signs, and ECG.	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15
b. Clinical Chemistry: CBC, LFT, RFT, Blood Glucose, Thyroid Profile.	1. Day 4, Day 8, and Day 15 | a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15 | b. at the time of screening and Day 15

Secondary Outcome Measures

Name	Time	Method
a. Single dose PK: Quantification of AB1001 concentration available in systemic circulation (blood/plasma) in all enrolled subjects; pre- and post first dosing with AB1001 gel on Day 1.	b. Multi dose PK: Quantification of AB1001 concentration available in systemic circulation (blood/plasma) in all enrolled subjects; pre- and post morning dosing with AB1001 gel on Day 14.

Trial Locations

Locations (1)

Veeda Clinical Research Pvt. Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

Veeda Clinical Research Pvt. Ltd.

🇮🇳Ahmadabad, GUJARAT, India

Dr Kiran Marthak

Principal investigator

079-67773000

Kiran.Marthak@veedacr.com