Healthy Adult VolunteersPhase 1NCT06008652
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers
A Phase 1 study testing DR-0201 in people with Healthy Adult Volunteers, run by Dren Bio at 1 site in Australia.
Trial summary
This is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- DR-0201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Nov 2023to 24 Jul 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, in the opinion of the Investigator, as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) outside the reference range for the population being studied that is not specifically listed in the inclusion or exclusion criteria may be included if the Investigator (in consultation with the Medical Monitor) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or data interpretation.
- Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Body weight at screening ≥ 40 kg and < 120 kg, with body mass index between 18 and 30 kg/m2.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol, including the protocol-mandate hospitalization.
- Use of a highly effective contraceptive measure (< 1% failure rate; see Section 13.1) for all males and all females of childbearing potential during study and 90 days post dose for males and 30 days post dose for females. Females of childbearing potential need to have a confirmatory urine pregnancy test on Day -1. Females who are not of childbearing potential (i.e., who are considered to be post-menopausal [≥ 12 months of non-therapy amenorrhea] or surgically sterile [absence
Who cannot join
- History or presence of a disease or condition that, in the Investigator's opinion, constitutes a risk when taking study drug or interfering with study assessment or interpretation of the data (e.g., autoimmune disease). Subjects post cholecystectomy are acceptable. Subjects with resolved childhood asthma not requiring prescription medicine are acceptable. Subjects with Gilbert's disease are acceptable if total bilirubin ≤3× ULN.
- Medical history of severe allergic reaction, angioedema, anaphylaxis, clinically significant drug hypersensitivity reaction, or autoimmune or immunodeficiency disorder.
- Active infection or a history of serious infections as follows:
- Use of antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic agents) for an infection within 30 days before first dose. Topical treatments may be allowed at the Medical Monitor's discretion.
- History of opportunistic infections in the last 2 years.
- Recurrent or chronic infection, or other active infection, that in the opinion of the Investigator might cause this study to be detrimental to the subject.
Show all 30Show fewer
- Symptomatic herpes zoster within 3 months prior to screening.
- History of tuberculosis (active or latent) irrespective of treatment status.
- Any history of viral hepatitis: hepatitis B virus, hepatitis C virus (HCV), hepatitis E virus.
- HCV is acceptable if HCV RNA is undetectable for at least 3 months post completion of direct-acting antiviral therapy.
- Any known history of John Cunningham virus (JCV) infection or progressive multifocal leukoencephalopathy (PML).
- Any planned major surgical procedure during the study.
- History of malignant neoplasm within the last 10 years, except for fully treated nonmetastatic basal or squamous cell cancers of the skin (within 3 years) that shows no evidence of recurrence.
- Use of prescription or non-prescription drugs (including recreational drugs and herbal medications) within 7 days or 5 half-lives (whichever is longer) prior to dosing, unless in the opinion of the Investigator (in consultation with the Medical Monitor), the medication will not interfere with the study or compromise subject safety. Paracetamol (acetaminophen) at doses of ≤ 4 grams/day, and occasional use of non-steroidal anti-inflammatory drugs at licensed doses, are permitted.
- Live or live-attenuated vaccination within 4 weeks of Day 1, or plan to receive a live vaccination during the study until follow-up.
- Previous exposure to DR-0201, or known hypersensitivity to biologics.
- Prior anaphylaxis to a biological agent or vaccine.
- Neutrophil or lymphocyte counts below the normal range.
- Estimated glomerular filtration rate by Chronic Kidney Disease Epidemiology Collaboration equation calculation ≤ 90 mL/min/1.73 m2 at screening.
- Alanine transaminase > 2× upper limit of normal (ULN) and bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) at screening. Bilirubin > 3 × ULN if known Gilbert's disease.
- Other clinically significant abnormalities of laboratory assessments, as judged by the Investigator and/or Medical Monitor, that could affect the safety of the subject, or the interpretation of the data from the study.
- Positive serology for human immunodeficiency virus (HIV) at screening.
- Positive drug/alcohol screen at screening or baseline.
- QT interval corrected for heart rate (QTc) > 450 msec, based on the mean of triplicate ECGs. The QTc is the QT interval corrected using Fridericia's formula (QTcF; preferred method), or another method, machine or overread.
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening. Heart rate is lower than 40 bpm or higher than 100 bpm at screening.
- Participation in a clinical trial and has received an investigational product within the following time period prior to screening in the current study: 3 months (for biologic therapies) or 1 month (for non-biologic therapies), 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Participation in a clinical study resulting in loss of blood or blood products in excess of 500 mL within 3 months prior to enrollment.
- Any other medical or psychiatric condition, or laboratory abnormality that would, in the opinion of the Investigator or Medical Monitor, increase the subject's risk of participation, jeopardize completion of the study, or compromise interpretation of the study data. Subjects receiving systemic medication for depression are not acceptable
- Unstable lifestyle factors (including but not limited to excessive alcohol use, heavy nicotine use, or substance abuse), to the extent that in the opinion of the Investigator they would interfere with the ability of a subject to complete the study. Up to four units of alcohol per week are allowed once the in-patient period is complete.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human Multiple Expansion Cohort Phase 1 Study Evaluating the Safety and Activity of DR-0201 as Single Ascending Dose in Healthy Volunteers
This is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy volunteers.
- Conditions
- Healthy Adult Volunteers
- Being tested
- DR-0201, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR-0201Drug
DR-0201 is a bi-specific antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DR-0201 | Experimental | Subjects in this arm will receive a single dose of DR-0201 Receives: Drug: DR-0201 |
| Placebo | Placebo comparator | Subjects in this arm will receive a single dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0 after a single IV dose
Measured: Up to 57 days
Secondary outcomes (4)
PK after a single IV dose: area under the plasma concentration time curve [AUC0-t].
Measured: Up to 57 days
PK after a single IV dose: maximum observed plasma concentration [Cmax].
Measured: Up to 57 days
PK after a single IV dose: time of occurrence of Cmax (tmax),
Measured: Up to 57 days
PK after a single IV dose: estimated half-life
Measured: Up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start26 Nov 2023
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dren Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech
- Responsible party
- Sponsor
- Investigators
- Matthias Will, MD, Study director, Dren Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008652
- Sponsor's protocol ID
- DR-0201-HV-001
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Multiple Expansion Cohort Phase 1 Study Evaluating the Safety and Activity of DR-0201 as Single Ascending Dose in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06008652
- Acronym / sponsor ID
- DR-0201-HV-001
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dren BioIndustry (pharma, biotech, devices)
- Collaborators
- Novotech
- Study start
- 26 Nov 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 23 Aug 2023 (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 is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DR-0201 | Experimental | Drug: DR-0201Subjects in this arm will receive a single dose of DR-0201 |
| Placebo | Placebo comparator | Drug: PlaceboSubjects in this arm will receive a single dose of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, in the opinion of the Investigator, as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) outside the reference range for the population being studied that is not specifically listed in the inclusion or exclusion criteria may be included if the Investigator (in consultation with the Medical Monitor) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or data interpretation.
- Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Body weight at screening ≥ 40 kg and < 120 kg, with body mass index between 18 and 30 kg/m2.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol, including the protocol-mandate hospitalization.
- Use of a highly effective contraceptive measure (< 1% failure rate; see Section 13.1) for all males and all females of childbearing potential during study and 90 days post dose for males and 30 days post dose for females. Females of childbearing potential need to have a confirmatory urine pregnancy test on Day -1. Females who are not of childbearing potential (i.e., who are considered to be post-menopausal [≥ 12 months of non-therapy amenorrhea] or surgically sterile [absence
Key exclusion criteria (30 listed)
- History or presence of a disease or condition that, in the Investigator's opinion, constitutes a risk when taking study drug or interfering with study assessment or interpretation of the data (e.g., autoimmune disease). Subjects post cholecystectomy are acceptable. Subjects with resolved childhood asthma not requiring prescription medicine are acceptable. Subjects with Gilbert's disease are acceptable if total bilirubin ≤3× ULN.
- Medical history of severe allergic reaction, angioedema, anaphylaxis, clinically significant drug hypersensitivity reaction, or autoimmune or immunodeficiency disorder.
- Active infection or a history of serious infections as follows:
- HCV is acceptable if HCV RNA is undetectable for at least 3 months post completion of direct-acting antiviral therapy.
- Any planned major surgical procedure during the study.
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 |
|---|---|---|
| DR-0201DR-0201 is a bi-specific antibody | Drug | DR-0201 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Safety and tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0 after a single IV dose
Time frame: Up to 57 days
4 secondary outcomes
PK after a single IV dose: area under the plasma concentration time curve [AUC0-t].
Time frame: Up to 57 days
PK after a single IV dose: maximum observed plasma concentration [Cmax].
Time frame: Up to 57 days
PK after a single IV dose: time of occurrence of Cmax (tmax),
Time frame: Up to 57 days
PK after a single IV dose: estimated half-life
Time frame: Up to 57 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Adult Volunteers
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Enrolling by invitation
Brain Stimulation Paired With Structured Language Learning in Adults
Language Development, Learning
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
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.
Matthias Will, MD study director
Dren Bio
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 DR-0201 in people with Healthy Adult Volunteers, run by Dren Bio at 1 site in Australia.
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 5 inclusion and 30 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: finished, as of the sponsor's last update on 13 Aug 2024. 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 Australia. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0 after a single IV dose (time frame: Up to 57 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.