HealthyPhase 1NCT03993704
Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants
A Phase 1 study testing LHF-535 in people with Healthy, run by Kineta Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LHF-535
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Sep 2019to 9 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of orally administered LHF-535 in 24 to 32 healthy adult participants. Three successive escalating cohorts, each containing 8 participants, are planned. Within each cohort, 6 participants will be randomized to receive an oral dose of LHF-535 once daily for 14 days, and 2 will be randomized to receive an oral dose of placebo once daily for 14 days. After a screening period of up to 28 days, all participants will be confined to the study center from 1 day prior to dosing until at least 24 hours after the 14th day of dosing. Participants will return for follow-up evaluations on Day 17 and Day 21 (72 and 168 hours after last dose, respectively) and on Day 42. After each cohort, safety data through Day 17 and PK data through Day 7 will be reviewed by a blinded Safety Committee prior to dosing of the next cohort. The Safety Committee is charged with making one of the following three recommendations: (1) proceed with dose escalation as planned, (2) continue the study with modification (e.g., proceed with the next cohort at a lower dose level than planned), or (3) suspend the study. An additional cohort of 8 participants may be added to evaluate dosing for future studies, at the discretion of the Sponsor, in consultation with the Safety Committee.
- Conditions
- Healthy
- Being tested
- LHF-535
- Keywords
- Lassa fever, viral hemorrhagic fever
- Medical subject headings
- Lassa Fever, Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHF-535Drug
Oral suspension administered once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 450 mg, 1125 mg, or 2250 mg of LHF-535 given once daily for 14 days Receives: Drug: LHF-535 |
| Placebo | Placebo comparator | Placebo to match LHF-535 given once daily for 14 days Receives: Drug: LHF-535 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability
Measured: 42 days
Secondary outcomes (1)
Area Under the Plasma Concentration versus Time Curve (AUC) of LHF-535
Pharmacokinetics
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start16 Sep 2019
- Primary completion9 Jan 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kineta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993704
- Sponsor's protocol ID
- KVHF-535-102
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03993704
- Acronym / sponsor ID
- KVHF-535-102
- Conditions
- Healthy
- Keywords
- Lassa fever, viral hemorrhagic fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kineta Inc.Industry (pharma, biotech, devices)
- Collaborators
- Wellcome Trust
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of orally administered LHF-535 in 24 to 32 healthy adult participants. Three successive escalating cohorts, each containing 8 participants, are planned. Within each cohort, 6 participants will be randomized to receive an oral dose of LHF-535 once daily for 14 days, and 2 will be randomized to receive an oral dose of placebo once daily for 14 days. After a screening period of up to 28 days, all participants will be confined to the study center from 1 day prior to dosing until at least 24 hours after the 14th day of dosing. Participants will return for follow-up evaluations on Day 17 and Day 21 (72 and 168 hours after last dose, respectively) and on Day 42. After each cohort, safety data through Day 17 and PK data through Day 7 will be reviewed by a blinded Safety Committee prior to dosing of the next cohort. The Safety Committee is charged with making one of the following three recommendations: (1) proceed with dose escalation as planned, (2) continue the study with modification (e.g., proceed with the next cohort at a lower dose level than planned), or (3) suspend the study. An additional cohort of 8 participants may be added to evaluate dosing for future studies, at the discretion of the Sponsor, in consultation with the Safety Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: LHF-535450 mg, 1125 mg, or 2250 mg of LHF-535 given once daily for 14 days |
| Placebo | Placebo comparator | Drug: LHF-535Placebo to match LHF-535 given once daily for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LHF-535Oral suspension administered once daily for 14 days | Drug | Active, Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v4.0
Time frame: 42 days
Safety and tolerability
1 secondary outcome
Area Under the Plasma Concentration versus Time Curve (AUC) of LHF-535
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LHF-535 in people with Healthy, run by Kineta Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v4.0 (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.