Healthy VolunteersPhase 1NCT05367661
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CHK-336 in Healthy Volunteers
A Phase 1 study testing CHK336 in people with Healthy Volunteers, run by Chinook Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of an investigational drug (CHK-336) when administered to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CHK336
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 19 Apr 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers must meet all the following inclusion criteria to be randomized:
- Male and female adults18 to 45years old, inclusive, at the time of consent.
- Body mass index (BMI) between 19 and 32 kg/m2, inclusive, (between 30.0 and < 40.0 kg/m2 for SAD Cohort A8) at screening.
- Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All participants (male or female) who are of childbearing potential must agree to use highly effective contraception during the study. Female participants must continue to use highly effective contraception during the study for 30 days after the last dose of study drug. Female participants should not donate oocytes during this time. Male participants with female partners of childbearing potential must continue to use highly effective contraception during the study and for 90 days after the last dose of study drug. Male participants must agree not to donate sperm during this time. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and Day -3 as well as a negative urine pregnancy test at Day 1 (predose). WOCBP must agree to undergo a pregnancy test during the study
- Female participants not of childbearing potential must be either surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or postmenopausal, defined as no menses for 12 months without an alternative medical cause, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges.
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- Willing and able to provide informed consent and comply with all study visits and procedures including overnight stays in the clinic
- Willing and able to comply with a pre-specified diet at least 72 hours prior to dose and throughout the study.
- Negative urine drug, tobacco, and breath alcohol test result at screening and Day-3.
- Have not used any nicotine-containing product within 3 months prior to the first study drug administration and who are willing to abstain throughout the study.
Who cannot join
- Healthy volunteers must not meet any of the following exclusion criteria to be randomized
- Any significant medical history including but not limited to hypertension, diabetes, cardiovascular disease, hemolysis, red blood cell disorders, and/or with clinically significant screening results outside the normal range for laboratory testing, vital signs, medical history, electrocardiograms (ECGs), physical examination as deemed by the investigator. Reticulocytes must be within normal range at screening and prior to dosing. Red blood cell (RBC), hemoglobin, and hematocrit must be within 5% of normal range at screening and prior to dosing.
- Evidence of chronic kidney disease (CKD) defined by an estimated glomerular filtration rate (eGFR) less than 80 mg/mL/1.73m2 based on the CKD epidemiology collaboration (EPI) equation or the presence of proteinuria at screening and prior to dosing.
- Have any known malignancy or history of malignancy, except for basal cell skin cancer that has been treated and with no evidence of recurrence for at least 3 months prior to the first study drug administration.
- History of liver disease, Gilbert's syndrome, or abnormal liver function test (AST, ALT, total bilirubin) above the normal reference range at screening and prior to dosing.
- Any active infection or acute illness within 30 days prior to the first study drug administration.
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- Major surgery or significant traumatic injury occurring within 28 days prior to first dose of study drug. If major surgery occurred > 28 days prior to first dose of study drug, individual must have recovered adequately from any toxicity and/or complications from the intervention prior to the first dose of study drug.
- Supine systolic blood pressure <90 or >140 mmHg, supine diastolic blood pressure <50 or >95 mmHg, pulse rate <40 or >100 beats per minute (bpm), or elevated body temperature (>38ºC) at screening and check-in
- History or presence of a clinically significant ECG abnormalities and QTcF >450 ms for males and >470 ms for females, prior to dosing.
- Positive serology tests for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
- Use of any prescription, vaccines, supplements/vitamins, or over-the counter medication (with the exception of oral contraceptives) within 7 days prior to the first study drug administration.
- Treatment with another investigational product within 30 days prior to the first study drug administration or within the expected washout (~5 half-lives) of the investigational product
- Prior exposure to CHK-336 (including Part A of this study).
- History or presence of alcohol abuse or drug use within 30 days prior to the first study drug administration and throughout the study
- Blood donation or significant blood loss within 60 days prior to the first study drug administration.
- Pregnancy, intent to become pregnant during the course of the study, or lactating women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
About this study
Official title: A Phase 1, Single-Center, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CHK-336 in Healthy Volunteers
This study is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of an investigational drug (CHK-336) when administered to healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- CHK336, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHK336Drug
Tablet
PlaceboDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Part A: Healthy Volunteers: Single ascending doses | Experimental | Six dose groups ranging from 15mg to 500mg, under fasting condition. Receives: Drug: CHK336; Drug: Placebo |
| Part A: Healthy Volunteer: Single Ascending dose under fed condition | Experimental | 60mg under fed condition. Receives: Drug: CHK336 |
| Part A: Otherwise Healthy volunteer with Class I or Class II obesity, Single Ascending dose | Experimental | 125mg, under fasting condition. Receives: Drug: CHK336; Drug: Placebo |
| Part B: Healthy Volunteers: Multiple Ascending doses | Experimental | 5 dose groups with doses ranging from 30mg to 500mg. Given daily for 14 days, under fasting condition. Receives: Drug: CHK336; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of CHK-336 in HV
Incidence, nature, and severity of adverse events (AEs), adverse events of special interest (AESI), and serious adverse events (SAEs)
Measured: Up to 28 days
Secondary outcomes (9)
Pharmacokinetic measure of Cmax
Maximum observed concentration of CHK -336 in plasma under fasted or fed condition
Measured: Up to 17 days
Pharmacokinetic measure of Tmax
Time to maximum observed concentration of CHK-336 in plasma under fasted or fed condition
Measured: Up to 17 days
Pharmacokinetic measure of AUC (0-∞)
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of CHK-336 in plasma under fed or fasted condition
Measured: Up to 17 days
Pharmacokinetic measure of AUC for up to 24 hours (AUC0-24)
The area under the concentration-time curve from time zero extrapolated to 24 hours post dose (AUC0-24) in plasma under fed or fasted condition
Measured: up to 17 days
Pharmacokinetic measure of AUC for up to last measurable time point (AUC0-T)
The area under the concentration-time curve from time zero extrapolated to last measurable timepoint (AUC0-T) of CHK-336 in plasma under fed or fasted condition
Measured: up to 17 days
Pharmacokinetic measure of apparent terminal half-life (t1/2)
Apparent terminal half-life (t1/2) of CHK-336 in plasma under fasted or fed condition
Measured: up to 17 days
Pharmacokinetic measure of exposure accumulation ratios of CHK-336
The exposure accumulation defined as the ratio of last dose to single dose AUC0-24h with once a day dosing
Measured: up to 17 days
Pharmacokinetic measure of exposure accumulation ratios (Cmax) for CHK-336
The exposure accumulation defined as the ratio of last dose to single dose Cmax with once a day dosing
Measured: up to 17 days
Pharmacokinetic measure of the amount of CHK-336 excreted in urine
Measure the amount of CHK-336 excreted in urine under fasted condition
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start8 Apr 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinook Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367661
- Sponsor's protocol ID
- CHK336-01
- Status last verified
- Nov 2023
- First submitted
- 5 Apr 2022
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cox JH, Boily MO, Caron A, Sheng T, Wu J, Ding J, Gaudreault S, Chong O, Surendradoss J, Gomez R, Lester J, Dumais V, Li X, Gumpena R, Hall MD, Waterson AG, Stott G, Flint AJ, Moore WJ, Lowther WT, Knight J, Percival MD, Tong V, Oballa R, Powell DA, King AJ. Characterization of CHK-336, A First-in-Class, Liver-Targeted, Small-Molecule Lactate Dehydrogenase Inhibitor for Hyperoxaluria Treatment. J Am Soc Nephrol. 2025 Apr 7;36(8):1535-1547. doi: 10.1681/ASN.0000000690.
PubMed 40193200
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CHK-336 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05367661
- Acronym / sponsor ID
- CHK336-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chinook Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 10 May 2022 (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.
This study is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of an investigational drug (CHK-336) when administered to healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Healthy Volunteers: Single ascending doses | Experimental | Drug: CHK336, Drug: PlaceboSix dose groups ranging from 15mg to 500mg, under fasting condition. |
| Part A: Healthy Volunteer: Single Ascending dose under fed condition | Experimental | Drug: CHK33660mg under fed condition. |
| Part A: Otherwise Healthy volunteer with Class I or Class II obesity, Single Ascending dose | Experimental | Drug: CHK336, Drug: Placebo125mg, under fasting condition. |
| Part B: Healthy Volunteers: Multiple Ascending doses | Experimental | Drug: CHK336, Drug: Placebo5 dose groups with doses ranging from 30mg to 500mg. Given daily for 14 days, under fasting condition. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male and female adults18 to 45years old, inclusive, at the time of consent.
- Body mass index (BMI) between 19 and 32 kg/m2, inclusive, (between 30.0 and < 40.0 kg/m2 for SAD Cohort A8) at screening.
- Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All participants (male or female) who are of childbearing potential must agree to use highly effective contraception during the study. Female participants must continue to use highly effective contraception during the study for 30 days after the last dose of study drug. Female participants should not donate oocytes during this time. Male participants with female partners of childbearing potential must continue to use highly effective contraception during the study and for 90 days after the last dose of study drug. Male participants must agree not to donate sperm during this time. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and Day -3 as well as a negative urine pregnancy test at Day 1 (predose). WOCBP must agree to undergo a pregnancy test during the study
- Female participants not of childbearing potential must be either surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or postmenopausal, defined as no menses for 12 months without an alternative medical cause, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges.
Key exclusion criteria (16 listed)
- Healthy volunteers must not meet any of the following exclusion criteria to be randomized
- Any significant medical history including but not limited to hypertension, diabetes, cardiovascular disease, hemolysis, red blood cell disorders, and/or with clinically significant screening results outside the normal range for laboratory testing, vital signs, medical history, electrocardiograms (ECGs), physical examination as deemed by the investigator. Reticulocytes must be within normal range at screening and prior to dosing. Red blood cell (RBC), hemoglobin, and hematocrit must be within 5% of normal range at screening and prior to dosing.
- Evidence of chronic kidney disease (CKD) defined by an estimated glomerular filtration rate (eGFR) less than 80 mg/mL/1.73m2 based on the CKD epidemiology collaboration (EPI) equation or the presence of proteinuria at screening and prior to dosing.
- Have any known malignancy or history of malignancy, except for basal cell skin cancer that has been treated and with no evidence of recurrence for at least 3 months prior to the first study drug administration.
- History of liver disease, Gilbert's syndrome, or abnormal liver function test (AST, ALT, total bilirubin) above the normal reference range at screening and prior to dosing.
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 |
|---|---|---|
| CHK336Tablet | Drug | Part A: Healthy Volunteer: Single Ascending dose under fed condition, Part A: Healthy Volunteers: Single ascending doses, Part A: Otherwise Healthy volunteer with Class I or Class II obesity, Single Ascending dose, Part B: Healthy Volunteers: Multiple Ascending doses |
| PlaceboTablet | Drug | Part A: Healthy Volunteers: Single ascending doses, Part A: Otherwise Healthy volunteer with Class I or Class II obesity, Single Ascending dose, Part B: Healthy Volunteers: Multiple Ascending doses |
Primary outcome
To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of CHK-336 in HV
Time frame: Up to 28 days
Incidence, nature, and severity of adverse events (AEs), adverse events of special interest (AESI), and serious adverse events (SAEs)
9 secondary outcomes
Pharmacokinetic measure of Cmax
Time frame: Up to 17 days
Pharmacokinetic measure of Tmax
Time frame: Up to 17 days
Pharmacokinetic measure of AUC (0-∞)
Time frame: Up to 17 days
Pharmacokinetic measure of AUC for up to 24 hours (AUC0-24)
Time frame: up to 17 days
Pharmacokinetic measure of AUC for up to last measurable time point (AUC0-T)
Time frame: up to 17 days
Pharmacokinetic measure of apparent terminal half-life (t1/2)
Time frame: up to 17 days
Pharmacokinetic measure of exposure accumulation ratios of CHK-336
Time frame: up to 17 days
Pharmacokinetic measure of exposure accumulation ratios (Cmax) for CHK-336
Time frame: up to 17 days
Pharmacokinetic measure of the amount of CHK-336 excreted in urine
Time frame: Up to 24 hours
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Derived from this study: PubMed 40193200Cox JH, Boily MO, Caron A, Sheng T, Wu J, Ding J, Gaudreault S, Chong O, Surendradoss J, Gomez R, Lester J, Dumais V, Li X, Gumpena R, Hall MD, Waterson AG, Stott G, Flint AJ, Moore WJ, Lowther WT, Knight J, Percival MD, Tong V, Oballa R, Powell DA, King AJ. Characterization of CHK-336, A First-in-Class, Liver-Targeted, Small-Molecule Lactate Dehydrogenase Inhibitor for Hyperoxaluria Treatment. J Am Soc Nephrol. 2025 Apr 7;36(8):1535-1547. doi: 10.1681/ASN.0000000690.
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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 CHK336 in people with Healthy Volunteers, run by Chinook Therapeutics, Inc. at 1 site in United States.
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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 3 Nov 2023. 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 United States. 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. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of CHK-336 in HV (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367661, which also lists 1 linked publication.
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 3 Nov 2023.