First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug;LPX-TI641

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase I First-in-Human, Randomized, Single-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Doses of LPX-TI641.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LAPIX Therapeutics Inc.

Criteria

Inclusion Criteria: Healthy volunteers (SAD and MAD sections)

1. Healthy volunteers (HV) with no known acute or chronic medical conditions (respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, etc.) at the time of enrollment.

2. All male and non-pregnant females aged 18-55 years old irrespective of their race and ethnicity.

3. Body Mass Index (BMI) 18.0-30.0 kg/m2, inclusive at screening.

4. Clinical laboratory evaluations performed at screening, including the white blood cell (WBC), hemoglobin (Hgb), platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), total bilirubin (T. Bili), lipase, blood urea nitrogen (BUN), creatinine, prothrombin time (PT), and partial thromboplastin time (PTT) are within acceptable normal reference ranges.

5. Subjects who are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient hospital stay, laboratory tests, and 12-lead ECG.

6. Contraception - All subjects (male and female) must agree to use any two of the contraception methods listed below. This criterion must be followed from the time of the first dose of study medication for 6 weeks after the last dose in females and for 90 days after the last dose for males.

a. The following applies to all female volunteers with childbearing potential and female partners of male volunteers enrolled in the study.

i. Implantable progestogen-only hormone contraception associated with inhibition of ovulation.

ii. Intrauterine device. iii. Intrauterine hormone-releasing system. iv. Bilateral tubal occlusion. v. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: Oral Intravaginal Transdermal Injectable vi. Progestogen-only hormone contraception (oral or injectable) is associated with inhibition of ovulation.

vii. Sexual abstinence -this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated about the duration of the study and the preferred and usual lifestyle of the participant.

viii. Cervical cap, diaphragm, or sponge with spermicide. b. The following applies to all male subjects in the study: i. Sexual abstinence- this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated for the duration of the study and the preferred and usual lifestyle of the participant.

ii. A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods).

iii. Vasectomy

Exclusion Criteria: Healthy volunteers (SAD and MAD sections)

1. History of cancer treatment with either chemo or radiation therapy or both in the past 5 years before enrollment in the study.

2. COVID-19:

The subject has COVID-19 positive status (confirmed by clinical signs and symptoms and a positive SARS-CoV-2 NAAT result COVID test) at any time during the screening period.

OR

has had recent COVID-19 vaccination including a booster dose in the past 30 days

OR

has received anti-viral therapy intended to prevent COVID-19 such as paxlovid, remdesivir, molnupiravir, interferons, Anti-SARS-CoV-2 monoclonal antibodies, IVIG SARS-CoV-2, COVID-19 Convalescent plasma, etc. within the past 30 days

3. Blood loss of >250 mL or donated blood within 56 days, or donated plasma within 7 days of screening.

4. Recent vaccination with live attenuated vaccines such as influenza, MMR, Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, Rabies vaccine, etc. in the past 30 days.

5. The subject has participated in another investigational study involving any investigational product within 60 days, or 5 half-lives, whichever is longer, before the first oral dose of the study drug.

6. Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study enrollment.

7. Involvement in the planning and conduct of the study (applies to CRO staff or staff at the study site).