A Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects

NCT05206201 | Completed Phase 1 DMC

• 1 other identifier: ZY19489 1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Double Blind, Parallel, Placebo-Control, Study Of ZY-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects aged between 18-55 years old (Both Inclusive).

Conditions

Malaria

Keywords

Malaria

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse event of ZY-19489 administered to healthy subjects.

  Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0 or higher) system will be used for reporting and grading

  For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30

Secondary Outcomes (13)

• Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)

  For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30

• Cmax

  For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30

• To assess the effect of ZY-19489/ZY-20486on the QTc interval (concentration/QTc modelling).

  For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30

• AUC0-∞

  For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30

• Tmax

  For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30

Study Arms (2)

ZY19489 Capsule

EXPERIMENTAL

Experimental study drug

Drug: ZY19489 Capsule

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo Capsule

Interventions

ZY19489 Capsule DRUG

Two part study with single and multiple dose

ZY19489 Capsule

Placebo Capsule DRUG

Two part study with single and multiple dose

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive who will be contactable and available for the duration of the trial and up to 2 weeks following the End of Study visit.
• Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18.5 to 30.0 kg/m2 (Both inclusive). BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in meters.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination and special investigations).
• Screening vital signs:
• Systolic blood pressure (SBP) - 90-140 mmHg, Diastolic blood pressure (DBP) - 60-90 mmHg, Heart rate (HR) 60-90 bpm.
• QTcF ≤450 ms, PR interval ≤220 ms.
• Female subjects with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) and be willing and able to continue contraception for 90 days after administration of study treatment.
• Male subjects must agree to use adequate contraception methods during the study and be willing and able to continue contraception for 90 days after administration of study treatment.
• Completion of the written informed consent process prior to undertaking any study related procedure.
• Must be willing and able to communicate and participate in the whole study.

You may not qualify if:

• Haematology, clinical chemistry or urinalysis results at screening that are outside of clinically acceptable laboratory ranges, and are considered clinically significant by the Investigator.
• Participation in any investigational product study within the 12 weeks preceding IMP administration.
• History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies, or history of anaphylaxis or other severe allergic reactions. Subjects with seasonal allergies/hay fever or allergy to animals or house dust mite that are untreated and asymptomatic can be enrolled in the study based on Investigator's discretion.
• Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma (excluding childhood asthma, or mild asthma with preventative asthma medication required less than monthly), epilepsy, or obsessive-compulsive disorder.
• History of malignancy of any organ system treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
• Subjects with history of schizophrenia, bi-polar disease, psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis.
• Subjects who have received psychiatric medications within 1 year prior to enrolment, or who have been hospitalized within 5 years prior to enrolment for either a psychiatric illness or due to danger to self or others.
• History of more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening.
• History of recurrent headache (e.g. tension-type, cluster or migraine) with a frequency of ≥2 episodes per month on average and/or severe enough to require medical therapy, during the 5 years preceding screening.
• Presence of clinically significant infectious disease or fever (e.g. sublingual temperature ≥38.5°C) within the 14 days prior to enrollment.
• Evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise subject safety.
• Significant inter-current disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, gastrointestinal, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis.
• Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. gastrectomy, diarrhoea).
• Blood donation of any volume within 1 month before IMP administration, or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to blood bank during the 12 weeks prior to IMP administration.
• Medical requirement for intravenous immunoglobulin or blood transfusions within 3 months prior to enrollment.

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (1)

Zydus Research Centre

Ahmedabad, Gujarat, 382213, India

Location

MeSH Terms

Conditions

Malaria

Interventions

ZY-19489

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Dr Deven Parmar, MD

  Zydus Therapeutics Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: January 25, 2022
• Study Start: August 25, 2021
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: July 11, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)