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A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects

PHASE1RECRUITING

This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.

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Study details:

This is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled KIT2014 administered via nebulizer to healthy adult participants. The study will be conducted in 2 parts, Part A (single ascending dose, SAD) and Part B (multiple ascending doses, MAD).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.

Adult males and females, 18 to 55 years of age (inclusive) at screening.

BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females.

Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities.

Normal spirometry results at Screening based on FEV1 ≥ 80% of predicted, FVC ≥ 80% of predicted and FEV1/FVC ratio ≥0.7.

Exclusion criteria

History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the PI to be clinically relevant.

Any respiratory infection or relevant respiratory problem within 14 days of Day 1.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-16

Primary completion: 2025-03-31

Study completion finish: 2025-04-30

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06659757

Intervention or treatment

DRUG: KIT2014

OTHER: Placebo

Conditions

• Cystic Fibrosis

Condition: Cystic Fibrosis
DRUG: KIT2014 and other drugs
Adelaide, South Australia, Australia
Sponsor: Kither Biotech Srl

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

CMAX Clinical Research Pty Ltd

Research sites nearby

Select from list below to view details:

CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A: Single Ascending Dose (SAD) Healthy volunteers - Up to 6 dose levels of KIT2014 will be evaluated in Part A. Dose levels will be investigated in sequential cohorts (A1 to A6) of 8 healthy participants per cohort (ratio 3:1 active:placebo).	DRUG: KIT2014 KIT2014 will be administered by inhalation with a nebuliser
EXPERIMENTAL: Part B: Multiple Ascending Dose (MAD) Healthy volunteers - Up to 3 dose levels of KIT2014 will be evaluated in Part B. Dose levels will be investigated in sequential cohorts (B1 to B3) of 8 healthy participants per cohort (ratio 3:1 active:placebo).	DRUG: KIT2014 KIT2014 will be administered by inhalation with a nebuliser

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)	Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after single and multiple inhaled administration of KIT2014 in healthy male and female participants.	Up to 10 days post-dose in SAD and up to 14 days after the last dose in MAD

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects