Clinical trial NCT06183671: JX09 SAD/MAD in Healthy Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Resistant Hypertension
Keywords: Hypertension
Health Volunteer
Pharmacokinetic
Food effect
Lead sponsor: Corxel Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2023-12-27
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blind, Placebo-Controlled, Multi-Part
Primary purpose: TREATMENT

Brief summary: This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 55 years (inclusive)
* In good health as deemed by the Investigator through a medical evaluation, including medical history, physical examination, and laboratory tests
* Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg at Screening

Exclusion Criteria:

* Clinically significant oncologic, infectious, cardiovascular, pulmonary, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, immunologic, renal, psychiatric, or other condition that in the opinion of the Investigator or Medical Monitor would make is unsafe for the participant to join the study or fulfill its requirements.
* A clinical abnormality or abnormal laboratory parameter(s) in the opinion of the Investigator or Medical Monitor is likely to introduce additional risk or will affect data interpretation.
* Postural tachycardia or hypotension.
* Female of childbearing potential who is pregnant, lactating, or planning to become pregnant.

Primary outcomes:
measure: The incidence of adverse events and serious adverse events in health subjects.
timeFrame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
measure: Clinically significant change from baseline in physical examinations in health subjects
timeFrame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
measure: Clinically significant change from baseline in vital signs in health subjects
timeFrame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
measure: Clinically significant change from baseline in electrocardiograms in health subjects
timeFrame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
measure: Clinically significant change from baseline in clinical laboratory tests in health subjects
timeFrame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
Secondary outcomes:
measure: Plasma pharmacokinetic parameters after a single ascending dose in health subjects
timeFrame: From Day 1 to Day 11
measure: Plasma pharmacokinetic parameters after a single ascending dose in health subjects
timeFrame: From Day 1 to Day 11
measure: Plasma pharmacokinetic parameters after a single ascending dose in health subjects
timeFrame: From Day 1 to Day 11
measure: Plasma pharmacokinetic parameters after a single ascending dose in health subjects
timeFrame: From Day 1 to Day 11
measure: Plasma pharmacokinetic parameters after a single ascending dose in health subjects
timeFrame: From Day 1 to Day 11
measure: Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
timeFrame: On day 1 and day 11
measure: Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
timeFrame: On day 1 and day 11
measure: Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
timeFrame: On day 1 and day 11
measure: Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
timeFrame: On day 1 and day 11
measure: Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
timeFrame: From day 2 to day 11
measure: Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
timeFrame: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
measure: Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
timeFrame: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
measure: Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
timeFrame: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
measure: Urine pharmacokinetic parameters after multiple ascending dose in health subjects
timeFrame: on day 1 and day 11
measure: Urine pharmacokinetic parameters after multiple ascending dose in health subjects
timeFrame: on day 1 and day 11
measure: Urine pharmacokinetic parameters after multiple ascending dose in health subjects
timeFrame: on day 1 and day 11
measure: Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
timeFrame: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
measure: Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
timeFrame: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
measure: Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
timeFrame: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
measure: Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
timeFrame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
measure: Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
timeFrame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
measure: Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
timeFrame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
measure: Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
timeFrame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
Study officials:
affiliation: Nucleus Network Pty Ltd.
name: Sam Francis, MD
role: PRINCIPAL_INVESTIGATOR
References: