Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants

NCT03993704 | Completed Phase 1 DMC

• 1 other identifier: KVHF-535-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a daily oral dose of LHF-535 administered for 14 days to healthy participants.

Conditions

Healthy

Keywords

Lassa fever; viral hemorrhagic fever

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v4.0

  Safety and tolerability

  42 days

Secondary Outcomes (1)

• Area Under the Plasma Concentration versus Time Curve (AUC) of LHF-535

  21 days

Study Arms (2)

Active

EXPERIMENTAL

450 mg, 1125 mg, or 2250 mg of LHF-535 given once daily for 14 days

Drug: LHF-535

Placebo

PLACEBO COMPARATOR

Placebo to match LHF-535 given once daily for 14 days

Drug: LHF-535

Interventions

LHF-535 DRUG

Oral suspension administered once daily for 14 days

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female 18 to 50 years of age, inclusive, at the time of screening
• Able to understand the requirements of the study, to provide written informed consent (as evidenced by signature on an informed consent document that is approved by a Human Research Ethics Committee \[HREC\]), and agreeable to abide by the study restrictions
• Body mass index (BMI) of 18.0 to 35.0 kg/m\^2, inclusive, at the time of screening
• Weight between 50 kg and 110 kg, inclusive, at the time of screening and check-in (Day -1)
• Good general health (e.g., no chronic health conditions such as hypertension, diabetes, chronic obstructive pulmonary disease, or cardiovascular disease) as determined by the Investigator; participants with mild allergies or benign conditions such as Gilbert's disease may be enrolled at the discretion of the Investigator
• Female participants of child-bearing potential, with a fertile male sexual partner, must use a highly effective method of contraception (oral contraceptive, intrauterine device, or hormonal patch, injectable, or implantable device) in conjunction with a male condom during the screening period and for the entire duration of study participation including the 28-day follow-up; true abstinence from sexual intercourse with a partner of the opposite sex, in accordance with the preferred and usual lifestyle of the participant, is acceptable; periodic abstinence or avoiding sexual intercourse on days while the participant is fertile (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), are not acceptable methods of contraception; non-childbearing potential is defined as postmenopausal as documented by an elevated follicle stimulating hormone (FSH) level or surgical sterility (e.g., tubal ligation, hysterectomy, and/or bilateral salpingo-oophorectomy)
• Male participants must either be surgically sterile (vasectomy) or agree to use a male condom as a method of contraception for the entire duration of the study and for 90 days after dosing; the female sexual partner must also use a medically acceptable form of birth control (e.g., oral contraceptive)
• Male participants must agree to not donate sperm for the entire duration of the study and for at least 90 days after dosing

You may not qualify if:

• Pregnancy or breastfeeding
• A positive screen for drugs of abuse, including alcohol; the screen may be repeated once (on Day-1) at the Investigator's discretion if a false-positive result is suspected
• Use of more than 5 tobacco- or nicotine-containing products per week (including but not limited to: cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 3 months prior to check-in (Day -1) or use of tobacco- or nicotine-containing products within 72 hours of check-in (Day -1) until discharge from the study unit
• Donated blood within 90 days or plasma within 30 days of dosing on Day 1
• Any history of anaphylaxis to medication, food, animal toxin or other substances
• Active substance abuse or any medical or psychiatric condition that could jeopardize the participant's safety
• Use of any medications apart from vitamins, acetaminophen, or hormonal contraception within 14 days of dosing on Day 1 (unless approved by the Investigator and Sponsor Medical Monitor); participants with mild allergies may use antihistamines at the discretion of the Investigator after approval by the Sponsor Medical Monitor
• Receipt of an investigational product within 12 weeks prior to dosing on Day 1 (or 5 half-lives, whichever is longer)
• Any history of cancer; non-melanoma skin cancer or cervical cancer in situ, resected surgically with no evidence of disease, may be enrolled at the discretion of the Investigator
• Receipt of an organ transplant (solid or hematopoietic), including corneal transplant
• Prolonged QTcF interval \>450 ms on electrocardiograms (ECGs) collected during screening, on Day -1, or just prior to dosing on Day 1 (following one repeat)
• Other clinically significant ECG abnormality, as determined by the Investigator
• Any clinically significant abnormal hematology, chemistry, or urinalysis value, as determined by the Investigator. Repeat testing is permitted at the discretion of the Investigator
• Positive test for human immunodeficiency virus (HIV serology) or known HIV infection
• Positive result for hepatitis B surface antigen (HBsAg) or for hepatitis C virus (HCV) antibody

Sponsors & Collaborators

• Kineta Inc.: lead
• Wellcome Trust: collaborator

Study Sites (1)

Centre for Clinical Studies

Melbourne, Australia

Location

MeSH Terms

Conditions

Lassa Fever; Hemorrhagic Fevers, Viral

Condition Hierarchy (Ancestors)

Arenaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

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

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: September 16, 2019
• Primary Completion: January 9, 2020
• Study Completion: June 9, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

AU (1)