Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03993704




Registration number
NCT03993704
Ethics application status
Date submitted
19/06/2019
Date registered
21/06/2019
Date last updated
9/07/2020

Titles & IDs
Public title
Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants
Scientific title
A Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of LHF-535 (LHF-535-SDD) in Healthy Participants
Secondary ID [1] 0 0
KVHF-535-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LHF-535

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

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


Treatment: Drugs: LHF-535
Oral suspension administered once daily for 14 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v4.0
Timepoint [1] 0 0
42 days
Secondary outcome [1] 0 0
Area Under the Plasma Concentration versus Time Curve (AUC) of LHF-535
Timepoint [1] 0 0
21 days

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- Use of alcohol-containing foods or beverages within 72 hours prior to check-in on Day
-1 or 72 hours prior to any study visit

- Use of caffeine-containing foods or beverages within 24 hours prior to check-in on Day
-1 until discharge from the study unit

- Strenuous exercise for 24 hours prior to check-in on Day -1 until discharge from the
study unit

- Febrile illness or significant infection within 48 hours before administration of the
first dose of study drug on Day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/06/2020
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Centre for Clinical Studies - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kineta Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Wellcome Trust
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03993704
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03993704