HealthyPhase 1NCT02217488
Single Ascending Dose Tolerability Study of DG3173
A Phase 1 study testing DG3173 in people with Healthy, run by Aspireo Pharmaceuticals Limited.
Trial summary
This clinical trial investigated the safety, tolerability and pharmacokinetic profile of DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1 study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via single dose subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DG3173
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Sep 2008
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ethnic origine: Caucasian
- Weight: 55-95 kg
- BMI: 19-29 kg/qm
- Medical history without clinically relevant pathologies
- Physical examination parameters and lung function without signs of clinically relevant pathologies
- Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <440ms
- Values for hematology, biochemistry and for coagulation tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the medical investigator (in particular normal values for ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, alpha-amylase and bilirubin)
- Having given written informed consent before any study-related activities are carried out
Who cannot join
- Evidence of clinically relevant pathology or disease
- Any history of moderate or severe hypertension, hypotension or orthostatic hypotension
- Mental handicap
- Legal incapacity
- Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
- Chronic diarrhea or other chronic gastrointestinal disorders
Show all 23Show fewer
- Acute or chronic gastro-duodenal ulcers
- Presence or history of endocrine disorders
- Presence or history of gall stone disease, presence excluded by means of upper abdominal ultrasound
- Known hypersensitivity to the study drug or constituent of the study drug
- History of any relevant allergy, especially drug and/or food allergies
- Strict vegetarian
- Regular treatment with medications during three months prior to randomization
- Receipt of any prescription or non-prescription medication, including multi-vitamin preparations within 14 days prior to drug administration and for the duration of the study
- Use of St. John´s Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization
- Participation in a clinical study within 30 days prior to randomization
- Donation of blood within 60 days prior to randomization
- History of use of tobacco or nicotine-containing products within the past three months
- Any history of alcohol abuse or drug addiction
- Positive results at screen for drugs of abuse (cocaine, amphetamine/methamphetamine, tetrahydrocannbinol, opiates) or alcohol (breath test) at screening or on admission
- Positive screen results for HBsAg, anti-HCV, or anti-HIV1\&2
- Consumption of abnormal quantities of coffee or tea (i.e. more than 5 cups per day [1 cup = 150 ml]
- Any disease which in the Investigator´s opinion would exclude the subject from the study
About this study
This clinical trial investigated the safety, tolerability and pharmacokinetic profile of DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1 study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via single dose subcutaneous injection.
- Conditions
- Healthy
- Being tested
- DG3173, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DG3173Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| DG3173 | Experimental | Not described Receives: Drug: DG3173 |
| Vehicle | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse events or withdrawals due to adverse events
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startMay 2008
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspireo Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DeveloGen AG, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217488
- Sponsor's protocol ID
- DG3173-I-001
- Status last verified
- Aug 2014
- First submitted
- 13 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Ascending Dose Tolerability Study of DG3173
- ClinicalTrials.gov ID
- NCT02217488
- Acronym / sponsor ID
- DG3173-I-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Aspireo Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Collaborators
- DeveloGen AG, Germany
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- First posted
- 15 Aug 2014 (estimated)
- 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 clinical trial investigated the safety, tolerability and pharmacokinetic profile of DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1 study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via single dose subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DG3173 | Experimental | Drug: DG3173 |
| Vehicle | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ethnic origine: Caucasian
- Weight: 55-95 kg
- BMI: 19-29 kg/qm
- Medical history without clinically relevant pathologies
- Physical examination parameters and lung function without signs of clinically relevant pathologies
Key exclusion criteria (23 listed)
- Evidence of clinically relevant pathology or disease
- Any history of moderate or severe hypertension, hypotension or orthostatic hypotension
- Mental handicap
- Legal incapacity
- Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
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 |
|---|---|---|
| DG3173 | Drug | DG3173 |
| Placebo | Drug | Vehicle |
Primary outcome
Number of serious adverse events or withdrawals due to adverse events
Time frame: One week
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 15 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DG3173 in people with Healthy, run by Aspireo Pharmaceuticals Limited.
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 8 inclusion and 23 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of serious adverse events or withdrawals due to adverse events (time frame: One week). 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 15 Aug 2014.