Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease

NCT05914909 | Completed Phase 1

• 1 other identifier: 1AD-AD-214-2301
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of a 10 mg/kg dose of AD-214 when administered to healthy volunteers (HVs) (Part A) or patients with interstitial lung disease (ILD) or chronic kidney disease (CKD) (Part B). The study will be performed in Australia at up to two clinical sites.

Conditions

Interstitial Lung Disease; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events that are related to treatment in healthy volunteers [Safety and Tolerability]

  Safety and Tolerability as assessed by the number of adverse events that are related to treatment versus placebo

  141 days

• Incidence of adverse events that are related to treatment in patients with ILD or CKD [Safety and Tolerability]

  Safety and Tolerability as assessed by the number of adverse events that are related to treatment versus placebo

  57 days

Study Arms (4)

Part A: AD-214 in Healthy Volunteers

EXPERIMENTAL

Biological: AD-214

Part A: Placebo in Healthy Volunteers

PLACEBO COMPARATOR

Other: Placebo

Part B: AD-214 in patients with ILD or CKD

EXPERIMENTAL

Biological: AD-214

Part B: Placebo in patients with ILD or CKD

PLACEBO COMPARATOR

Other: Placebo

Interventions

AD-214 BIOLOGICAL

AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.

Part A: AD-214 in Healthy Volunteers; Part B: AD-214 in patients with ILD or CKD

Placebo OTHER

Placebo

Part A: Placebo in Healthy Volunteers; Part B: Placebo in patients with ILD or CKD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Study Parts:
• Male or female aged ≥ 18 to ≤ 65 years of age at the time of consent.
• Provision of signed informed consent prior to study entry and agreement to adhere to all study protocol requirements.
• Agreement to adhere to the current state and national advice regarding minimising exposure to corona virus disease from the first screening visit until the EoS visit.
• Maximum weight of 100.00 kg and BMI \> 18.0 and \< 30.0 kg/m2 (inclusive) at the time of consent. Participants must also be \< 100.00 kg at Day -1.
• Normal vital signs after ≥ 5 minutes resting supine position:
• \> 90 mmHg and \<160 mmHg SBP
• mmHg and \< 95 mmHg DBP
• \> 45 bpm and \< 101 bpm HR
• Body temperature \>35.5oC and ≤37.6°C
• Ability and willingness to attend the necessary visits to the CRU.
• Have established use of highly effective, double barrier contraception (both partners) prior to screening, during the study AND for 90 days following completion of dosing as specified below in this criterion.
• Double barrier contraception is defined as a condom AND 1 other form of the following:
• Hormonal and non-hormonal forms of contraception (including oral, depot or injectable)
• IUD/IUS

You may not qualify if:

• All Study Parts:
• Previously received AD-214
• Received any IMP within 30 days or 5 half-lives prior to Screening, whichever is longer.
• Received an investigational vaccine, recombinant protein or monoclonal antibody within 6 months, a live attenuated registered vaccine within 60 days, or a registered vaccine within 30 days prior to the first dose of the IP.
• Received blood or blood products within 1 month prior to Screening.
• Blood donation or significant blood loss (\> 280 mL) within 60 days prior to the first dose of the IP.
• Plasma donation within 7 days prior to the first dose of the IP.
• A bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
• Unable to provide a blood sample without undue trauma or distress or inadequate venous access.
• Recent (less than 6 weeks) significant wound (in the opinion of the PI), or presence of an ongoing non-healing skin wound on Day -1.
• Positive test for HIV, HBsAg, or anti-HCV at Screening.
• A psychiatric condition that precludes compliance with the protocol in the opinion of the Investigator; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to Screening, a history of suicide plan.
• Clinical signs of active infection and/or a temperature of \> 37.7°C at the time of Screening. Study entry may be deferred at the discretion of the PI.
• Fever in the past 7 days within Screening or Day 1 AND symptoms reflective of an active respiratory tract infection (in the opinion of the Investigator).
• QTcF \> 450 msec for females and \> 470 msec for males, or QTcF \> 480 msec in participants with Bundle Branch Block.

Sponsors & Collaborators

• AdAlta Limited: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emir Redzepagic, Dr

  CMAX Clinical Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 22, 2023
• Study Start: July 17, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)